Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- Evaluate the sensitivity and specificity of the following Methinks AI modules:
研究概览
简要总结
The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms.
The main question[s] it aims to answer is:
• Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.
详细描述
This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in consecutive acute Code Stroke activations at the emergency department.
Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)
Informed consent forms (ICF) will be waived, as approved by the IRB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of final Stroke diagnosis.
- •Subjects aged 22 years or older.
- •NCCT performed for Code Stroke screening.
- •If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
- •NCCT and CTA have been processed by Methinks AI software.
排除标准
- •● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
结局指标
主要结局
Evaluate the sensitivity and specificity of the following Methinks AI modules:
时间窗: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
1. Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions. 2. Methinks NCCT algorithm detecting ICHs. 3. Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.
次要结局
- Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.(Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).)
- Time for NCCT-LVO Notification.(Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).)
- User experience.(1 day (Questionnaire completed at individual site enrollment completion.))